Cardiol Therapeutics

Cardiol Therapeutics is a leader in producing the purest pharmaceutical CBD products and developing innovative therapies for heart disease.

This Cardiol Therapeutics profile is part of a paid investor education campaign.*

Overview

Cardiol Therapeutics Inc. (TSX:CRDL; OTCQX:CRTPF) is focused on producing the purest pharmaceutical CBD products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The company’s lead product, CardiolRx, is designed to be the safest and most consistent CBD formulation on the market. CardiolRx is pharmaceutically produced, cGMP-certified, and does not contain any THC. Cardiol plans to commercialize CardiolRx during 2019 in the billion-dollar market for medicinal cannabinoids in Canada and is pursuing distribution opportunities in Europe and Latin America.

Cardiol is developing a unique expertise in the production of pharmaceutical cannabinoids in support of its nanotherapeutics program in heart failure and its recently announced orphan drug program in acute myocarditis. The company believes there is a significant opportunity to commercialize a line of pure pharmaceutical CBD products in the growing market for medical cannabinoids.

Cardiol has exclusive partnerships with Noramco Inc. and Dalton Pharma Services to produce CardiolRx, Cardiol’s pharmaceutical CBD that is THC free. Through these partnerships, Cardiol is commercializing one of the most advanced formulations of pharmaceutical CBD, leading a market that is now estimated to exceed $600 million in Canada alone. The company has recently completed the manufacturing scale-up for its commercial launch of CardiolRx 100 CBD formulation.

In collaboration with researchers and opinion leaders at international centers of excellence, including the University of Alberta, the Houston Methodist DeBakey Heart & Vascular Center and TecSalud del Tecnológico de Monterrey, Mexico, Cardiol is leveraging multidisciplinary expertise in drug delivery, drug formulation, nanotherapeutics, cardiac physiology and heart failure. The company’s research collaborations provide Cardiol with the optimal platform on which to pursue the commercial development of new therapies for heart failure, a leading cause of death and disability in the western world.

Cardiol’s nanotechnology has been shown in a pre-clinical model of heart failure to target the failing heart and deliver drugs to the site of inflammation. The company has also recently announced that it intends to conduct an orphan drug program for acute myocarditis. Acute myocarditis is characterized by inflammation of the heart muscle. The most common cause is a viral infection of the heart tissue which is initially responsible for the inflammation. The program is expected to help build brand awareness for the company’s upcoming product launch.

The company’s management team has extensive experience in the research and commercial development of novel therapeutics. Additionally, management is notably invested in the company, holding approximately 35 percent of the outstanding shares.

Cardiol Therapeutics’ Company Highlights

  • Commercializing one of the most advanced formulations of pharmaceutical cannabidiol, leading a market estimated to exceed $600 million in Canada alone.
  • Initiating an orphan drug program for acute myocarditis.
  • Implementing nanotechnologies to deliver CBD and other anti-inflammatory drugs for the treatment of diastolic heart failure.
  • Exclusive partnerships with Noramco, Inc. and Dalton Pharma Services.
  • Ongoing research programs at the University of Alberta, the Houston Methodist DeBakey Heart & Vascular Center and TecSalud del Tecnológico de Monterrey, Mexico.
  • Management holds approximately 35 percent of the company’s shares.

Pharmaceutically Manufactured CBD

Cardiol has exclusive partnerships with Noramco Inc. and Dalton Pharma Services, both of which are FDA-certified and operate under cGMP standards, to produce CardiolRx, Cardiol’s pharmaceutical CBD that is THC free. Through these partnerships, Cardiol is commercializing one of the most advanced formulations of pharmaceutical CBD, leading a market that is now estimated to exceed $600 million in Canada alone. The company has recently completed the manufacturing scale-up for its commercial launch of CardiolRx 100 CBD formulation.

The market for medical cannabinoids

According to a report by New Frontier Data, the Canadian cannabis market is expected to reach $9.2 billion by 2025. Part of this growth is being driven by the advances in medical applications of CBD as more research is conducted regarding its beneficial effects. Growth could be driven by the need to find an alternative to using opioids, which can be highly addictive, to treat chronic pain. Markets are also opening up in Europe and Latin America, where in select countries CBD is being sold as an over-the-counter product in pharmacies. The European medical cannabis market is expected to exceed $60 billion within a decade and the Latin American market is expected to reach $2.5 billion by 2026.

According to Statistics Canada, medical cannabis users are also concerned about the quality and safety of the cannabis they use, which could play a big role in where consumers buy their cannabis.

Orphan Drug Program for Acute Myocarditis

In June 2019, Cardiol announced its intent to complete an international clinical trial for acute myocarditis, an inflammation of the heart muscle commonly caused by a viral infection of the heart tissue, utilizing its CardiolRx CBD formulation. The program is expected to build brand awareness in support of the company’s commercial launch of CardiolRx and is being designed by an independent steering committee comprised of thought-leaders in cardiology in North America and Europe. Orphan Drug programs in the US and EU are eligible for accelerated marketing approvals and other incentives, including a prolonged period of market exclusivity.

“The US orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy and significant shareholder value was created in the process,” stated Cardiol President and CEO David Elsley. “Given the mortality and the significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our CardiolRx pharmaceutical CBD formulation for this serious orphan disease which has no accepted standard of care.”

Cardiol Therapeutic’s Heart Failure Program

People with heart failure suffer from a variety of ailments, including shortness of breath, rapid heart rate, edemas, reduced exercise capacity, can often struggle with simple daily activities, and are frequently hospitalized. Many of these symptoms can significantly reduce the quality of life for an individual.

There are two types of heart failure: systolic and diastolic. Systolic heart failure, or heart failure with reduced ejection fraction (HFrEF), occurs when the left ventricle cannot adequately pump blood from the heart and into circulation. Diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF), occurs when the left ventricle becomes stiff and doesn’t relax as it should and, as a result, cannot fill properly, causing pressure to build in the left side of the heart and in the lungs. This results in a patient feeling shortness of breath and is associated with health concerns such as obesity, hypertension and diabetes.

Another complication that can be experienced by those suffering from HFpEF is chronic inflammation, which can lead to a decrease in blood vessel function, impairment of heart muscle function, and fibrosis, which results in stiffness in the heart and a reduction in pumping efficiently. Over the past 20 years, there have been little to no significant treatments developed for HFpEF, as therapies have primarily remained focused on diuretics.

The market

More than 26 million people across the globe are affected by chronic heart failure. Of this number, six million are based in Canada and the US, making heart failure a leading cause of death and hospitalization in the region. In the US alone, the associated health costs exceed $30 billion annually.

To combat the effects of heart disease and to create a better quality of life for patients, Cardiol is developing a portfolio of patented, innovative nanotherapeutics that utilize anti-inflammatory drugs to treat cardiac tissue that is experiencing inflammation and fibrosis.

Products

CTX01

CTX01 is Cardiol’s proprietary formulation of pharmaceutical cannabidiol being developed for the treatment of HFpEF.

Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.

Cannabidiol is lipid soluble, virtually insoluble in water, highly sensitive to deactivation in the liver via first-pass metabolism and is rapidly cleared from the body. This results in low active blood levels and overall bioavailability of less than 10 percent when taken orally. Cardiol’s CTX01 formulation for subcutaneous administration is designed to avoid first-pass metabolism, optimize and maintain blood levels of the drug, and target cannabidiol to areas of inflammation and increased fibrosis in the heart. Cardiol believes that overcoming the low bioavailability issues associated with cannabidiol and targeting the drug to sites of disease could significantly broaden the therapeutic potential of this molecule.

Patented nanotechnology for drug formulation and delivery

Most drugs in development are fat-soluble, making them incompatible with water-based blood circulation. In order to address this limitation, Cardiol has developed a patented nanotechnology solution that combines a fat-compatible core with a water-compatible shell. These combined features and the polymeric nanostructures are designed to enhance solubilization of fat-soluble drugs, enhance circulating drug levels and target drugs to the specific sites of disease.

Work conducted in an experimental model of heart failure by the Houston Methodist DeBakey Heart & Vascular Center has shown that Cardiol’s nanotechnology preferentially accumulates, particularly when it comes to heart inflammation. The nanotechnology is designed to target sites of inflammation and there is potential for it to direct drugs to the sites of disease.

Cardiol Therapeutic’s Strategic Partnerships

Noramco

Founded in 1979 and headquartered in Delaware, USA, Noramco maintains operations around the world and is a global leader in the manufacture and supply of controlled drug substance Active Pharmaceutical Ingredients (APIs), including select cannabinoids (CBD).

Cardiol has an exclusive supply agreement with Noramco for the manufacture and supply of pure pharmaceutical CBD in Canada and Mexico.

Dalton Pharma Services

Cardiol has established an exclusive manufacturing arrangement with Dalton Pharma Services (Dalton) for the supply of pharmaceutical CBD for commercial introduction and for Cardiol’s research programs.

Located in Toronto, Canada, Dalton is a Health Canada approved, FDA registered, cGMP manufacturer of over 200 Active Pharmaceutical Ingredients (APIs), including pharmaceutical cannabinoids, with manufacturing capability scalable to support all stages of the regulatory process (Phase I, II, III and commercial). In 2016 and 2017, Dalton Pharma Services received the Leadership Award for Contract Manufacturing Organizations (CMO) in the following categories: Quality, Capabilities, Expertise, Compatibility and Development.

Dalton is also the manufacturer of Nabilone, the largest prescription pharmaceutical cannabinoid in the world, with annual sales of $100 million in Canada alone.

As part of the partnership, Dalton is also a significant shareholder in Cardiol. Dalton’s founder, owner and CEO, Peter Pekos, is on Cardiol’s board.

In collaboration with Noramco, Inc. and Dalton Pharma Services, Cardiol is producing CBD in support of the company’s heart disease programs and for the commercial introduction of its CardiolRx CBD products into the Canadian medicinal cannabinoid market. Cardiol believes this new class of cannabidiol-based products will set new industry standards for product purity, traceability, dosimetry, and consistency while providing the Company with a significant revenue opportunity.

Cardiol Therapeutic’s Research Collaborations

University of Alberta

Cardiol’s research program at the University of Alberta is focused on the development of proprietary nanoformulations of anti-inflammatory drugs designed to enhance the compatibility of drugs with the aqueous blood circulation, improve pharmacokinetics, and increase drug concentration at the site of disease.

The Company’s research program is being conducted under the direction of Dr. Afsaneh Lavasanifar, Professor in the Pharmaceutical Sciences at the University of Alberta, and a recognized expert in pharmaceutics, nanomedicines, and drug formulation.

In 2007, the University of Alberta and the Government of Canada collaborated to create the National Institute of Nanotechnology, the mission of which is to transform nanoscience ideas into novel, sustainable nanotechnology solutions.

DeBakey Heart and Vascular Center

Cardiol is conducting experimental research at the Houston Methodist DeBakey Heart & Vascular Center, designed to investigate the activity of the Company’s proprietary nanotechnology in a model of non-ischemic cardiomyopathy.

The Houston Methodist DeBakey Heart & Vascular Center is recognized internationally as a center of excellence for the treatment of heart failure. The center was the birthplace of cardiovascular bypass surgery in 1964 and is currently ranked the 14th best hospital for care in cardiology and heart surgery out of 5,028 hospitals in the United States.

TecSalud del Tecnológico de Monterrey

Cardiol is collaborating with TecSalud del Tecnológico de Monterrey (TecSalud) on research and development of proprietary nanotherapeutics for the treatment of heart failure. The primary objective of this collaboration is to develop the experimental evidence necessary to support advancing breakthrough nanomedicines for heart failure into clinical development during 2019.

TecSalud has collaborative relationships with the Houston Methodist DeBakey Heart & Vascular Center and the University of Calgary and has established a formal agreement with the Massachusetts Institute of Technology (MIT) to promote research and development in nanoscience and nanotechnology in Mexico.

Cardiol Therapeutics’ Management Team

David Elsley, MBA — President, CEO and Director

Founder and CEO of Vasogen Inc., with 25 years of experience developing, financing and managing all aspects of corporate development of biotechnology and high-growth organizations.

Eldon R. Smith, OC, LLD (Hon), MD, FCAHS, FCCS, FRCPC — Chief Medical Officer and Chairman

Cardiologist; former Head of Cardiology, former Chairman of Medicine, former Dean of Medicine, University of Calgary;

Chair Steering Committee, Canadian Heart Health Strategy; recipient of Order of Canada.

Chris Waddick, MBA, CPA, CMA — Chief Financial Officer

Thirty years of experience in financial and executive roles in the biotechnology and energy industries, former Chief Financial Officer and Chief Operating Officer of Vasogen Inc.

Anne Tomalin, BA, B.Sc., RAC — Director of Regulatory Affairs

Founder of CanReg Inc and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies respectively. An expert in regulatory affairs in Canada, United States and Europe.

Thomas Moffat, BBA – Chief Commercial Officer

TextSenior operations and retailing executive with an extensive background in the pharmaceutical environment; over 20 years tenure at Shoppers Drug Mart.

Iain Chalmers, MBA — Chief Marketing Officer and Director

Strategic Marketing and Innovation. Former Vice-President marketing and innovation at Diageo, the world’s largest spirits company. Professor of Marketing at Centennial College Business School.

Anthony E. Bolton, B.Sc., Ph.D., D.Sc. — Director of Research

Immunologist, 20+ years of experience in biotechnology, Chief Scientific Officer of Vasogen Inc.; former Professor and Department Head of Biomedical Sciences, Sheffield, UK.

Blagoja Ristevski, B.Sc., CHE — Director of Chemical Engineering and Manufacturing

Chemical Engineer, 25+ years of experience in the biopharmaceutical industry, senior exec. roles in eight Canadian biopharmaceutical Co.’s in the research/discovery of drug products; VP Product Dev., AMRIC Institute, Ontario, Canada.

Guillermo Torre-Amione, MD, Ph.D. — Director

President of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. Former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.

Peter Pekos, B.Sc., M.Sc. — Director

President, CEO and Founder at Dalton Pharma Services with broad experience in the research, development and commercialization of pharmaceuticals, products and services.

Deborah Brown, MBA — Director

Partner at Accelera Canada with multiple years advising pharmaceutical clients in strategy and initiatives, market research, market access and regulatory affairs. Previously President, EMD Serono Canada (division of Merck KGaA, Merck Serono).

Terry Lynch, B.BA. (Hon) — Director

Chairman, Chilean Metals Inc., Founder of Pallet Pallet and Partner with Kingsmill Capital; entrepreneur with extensive experience and expertise in financing the development of new technologies.


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